Regulatory Focus™ > News Articles > As EMA Gives Ranbaxy Facility Banned by FDA the All-Clear, Mutual Reliance Questions at Forefront

As EMA Gives Ranbaxy Facility Banned by FDA the All-Clear, Mutual Reliance Questions at Forefront

Posted 05 June 2014 | By Alexander Gaffney, RAC 

As EMA Gives Ranbaxy Facility Banned by FDA the All-Clear, Mutual Reliance Questions at Forefront

European regulatory officials have announced that they found no serious issues at Indian pharmaceutical manufacturer Ranbaxy's plant in Toansa, India, putting them at odds with the US Food and Drug Administration (FDA), which had banned products manufactured at the plant from entering into the US in January 2014.

Background: Compliance Problems at Toansa

FDA's actions followed a September 2013 inspection of the facility, which yielded a Form 483 from the agency outlining an extensive number of troubling deficiencies. For example, FDA said it found Ranbaxy to be handling data improperly, "over-writing electronic raw data files for ongoing sample sequences until acceptable results [were] achieved." In other cases, data results were not recorded, samples were not analyzed in accordance with established laboratory test method procedures, officially recorded data was found to be different than the data obtained from testing, and computer systems lacked adequate controls, among other problems.

In essence, FDA all but explicitly accused Ranbaxy—which had just two years earlier pleaded guilty to felony charges in FDA's largest false claims case ever—of fabricating its data and seeking to mislead regulators.

In January 2013, FDA announced that the site would be subject to an import alert, prohibiting any of its products from being distributed in the US, and also subjecting it to the same consent decree that now covers many of Ranbaxy's other facilities in the wake of its fraud conviction.

Ranbaxy suspended all shipments from the plant a month later, affecting the availability of its products in the EU and India. So far the 483 has not resulted in a Warning Letter from FDA, though similar findings at other Indian pharmaceutical manufacturing facilities have yielded Warning Letters in at least 10 cases.

EMA Gives the All-Clear

Now the plant has received what is perhaps its first piece of good news in months.

On 6 June 2014, the European Medicines Agency (EMA) announced that it had inspected the plant and found that it posed "no risk to public health."

The regulator had, following FDA's inspection of the site, suspended the site's good manufacturing practice (GMP) certificate.

But after EMA said its inspectors had a chance to inspect the facility itself, it would be reinstating that certificate. While the assessment indicated that there were still "a number of GMP deficiencies at the [Toansa] site," EMA said that an "assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies."

Despite indications that the site has brought many of its problems under control, the site will be kept under "close supervision," EMA said.

Evidence of Friction?

Meanwhile Reuters reports that FDA shows no signs of lifting its import alert against the Toansa site, indicating that while regulators had found varying levels of deficiencies at the site, they were being interpreted by "differing regulators and legal standards."

Such a major discrepancy—one region giving the all-clear while another gives the cold shoulder—could prove problematic for regulators, however.

FDA and EMA have recently begun to implement new quality agreements meant to increase cooperation between the two regulators, allowing them to mutually rely upon on each other’s facility inspection findings. In December 2013, the two implemented the Generic Drug Applications Inspections Initiative (GDAI Initiative), focused on generic drug products. And in May 2014, the two launched a new pharmaceutical quality initiative focused on drug quality more wholly.

Such a major difference in response to similar—if not the same—quality inspection information highlights some of the challenges inherent in any approach based on mutual reliance.

While the approach clearly holds promise for both EU and US officials, the Toansa case indicates that mutual inspections are unlikely to be a panacea for either region.

 

EMA Statement

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